Chugai Obtains Approval for FoundationOne CDx Cancer Genomic Profile as a Companion Diagnostic of Lorlatinib for ALK Fusion Gene-Positive Non-Small Cell Lung Cancer

TOKYO, September 18, 2026 -- Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) announced that it has obtained approval from the Ministry of Health, Labour and Welfare (MHLW) on September 10, 2026 for FoundationOne ® CDx Cancer Genomic Profile to be used as a companion diagnostic for Pfizer Japan Inc’s third-generation ALK inhibitor, LORBRENA ® tablets 25 mg and 100 mg (generic name: lorlatinib), which is approved for ALK fusion gene-positive non-small cell lung cancer (NSCLC). This approval enables the detection of ALK fusion genes using the FoundationOne CDx Cancer Genomic Profile to guide the decision to use lorlatinib for ALK fusion gene-positive NSCLC. FoundationOne CDx Cancer Genomic Profile has continuously expanded its companion diagnostic capabilities, enabling a single comprehensive genomic profiling test to support treatment decisions for multiple medicines. With this approval, the availability of companion diagnostics for ALK fusion gene-positive NSCLC will be further expanded, which is expected to enhance patient access to appropriate treatment options. As a leading company in oncology, Chugai is committed to realizing more advanced personalized healthcare in the oncology field and contributing to patients through the wider adoption of comprehensive genomic profiling. Approval information The underlined and bolded part has been newly added. Intended uses or indications The product is used for comprehensive genomic profiling of tumor tissues in patients with solid cancers. The product is used for detecting gene mutations and other alterations to support the assessment of drug indications listed in the table below. Alterations Cancer type Relevant drugs Activated EGFR alterations Non-small cell lung cancer (NSCLC) afatinib, erlotinib, gefitinib, osimertinib EGFR exon 20 T790M alterations osimertinib ALK fusion genes alectinib, crizotinib, ceritinib, brigatinib, lorlatinib ROS1 fusion genes entrectinib MET exon 14 skipping alterations capmatinib BRAF V600E and V600K alterations Malignant melanoma dabrafenib, trametinib, vemurafenib, encorafenib, binimetinib BRAF V600 alterations and BRAF fusion genes Glioma tovorafenib ERBB2 copy number alterations (HER2 gene amplification positive) Breast cancer trastuzumab AKT1 alterations capivasertib PIK3CA alterations PTEN alterations KRAS/NRAS wild-type Colorectal cancer cetuximab, panitumumab Microsatellite instability high nivolumab Microsatellite instability high Solid tumors pembrolizumab Tumor mutational burden high pembrolizumab NTRK1/2/3 fusion genes entrectinib, larotrectinib, repotrectinib RET fusion genes selpercatinib ALK fusion genes alectinib BRCA1/2 alterations Ovarian cancer olaparib BRCA1/2 alterations Prostate cancer olaparib FGFR2 fusion genes Biliary tract cancer pemigatinib About FoundationOne CDx Cancer Genomic Profile Developed by Foundation Medicine Inc. , FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan. Trademarks used or mentioned in this release are protected by law.

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